Mandible FractureSCAONCT04907552
Forensic Dental Age Estimation : Validation of Computed Tomography for Third Molar Demirjian's Staging
An observational study of Mandible Fracture, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993). Read more about this study
- Who is it for?
- Ages 0 to 25 years
- Conditions the study is for
- Mandible Fracture
- How many people
- 557 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient aged between 0 and 25 years old
Who may be able to join
- Patient aged between 0 and 25 years old
- Complete dental panoramic
- CT scan including mandible and maxilla
- Maximum of 2 months between CT scan and dental panoramic
- Medical imaging available on the PACS
Who cannot join
- Medical imaging missing on the PACS
- Patient refuses to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34295
Catherine CYTEVAL, MD.PhD, 04 67 33 81 78 ext. 33, c-cyteval@chu-montpellier.fr
Celine ENGRAND, MD, PhD, c-engrand@chu-montpellier.fr
About this study
Official title: Forensic Dental Age Estimation : Validation of Computed Tomography for Third Mandibular Molar Demirjian's Staging Method in a 0- 25 Years French Living Population
Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993).
More recently, reviews indicate the Computed tomography (CT) scan of the medial clavicular epiphysics can contribute to improve the accuracy of individual's age estimation (Houpert, 2016).
Furthermore, with the recent advances, the very low dose CT scan acquisitions can be perform with sufficient quality for the teeth analysis.
The goal of this study is to validate the use of dental CT for Demirjdian's staging method.
- Conditions
- Mandible Fracture
- Keywords
- Dental age estimation, CT scan, dental panoramic, Validation CT scan, Radiography
- Medical subject headings
- Mandibular Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
weighted Kappa test between CT scan
weighted Kappa test between CT scan and dental panoramic assessment of Demirjian's staging of third mandibular molar
Measured: day 1
Secondary outcomes (2)
Mineralization difference
Mineralization difference between mandibular and maxillar third molar
Measured: day 1
Dental age estimation in a south french population
Dental age estimation in a south french population
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Nov 2020
- Primary completion1 Nov 2021 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandible FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 557 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine CYTEVAL, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907552
- Sponsor's protocol ID
- RECHMPL20_0576
- Acronym
- SCAO
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forensic Dental Age Estimation : Validation of Computed Tomography for Third Mandibular Molar Demirjian's Staging Method in a 0- 25 Years French Living Population
- ClinicalTrials.gov ID
- NCT04907552
- Acronym / sponsor ID
- SCAO / RECHMPL20_0576
- Conditions
- Mandible Fracture
- Keywords
- Dental age estimation, CT scan, dental panoramic, Validation CT scan, Radiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 557 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993).
More recently, reviews indicate the Computed tomography (CT) scan of the medial clavicular epiphysics can contribute to improve the accuracy of individual's age estimation (Houpert, 2016).
Furthermore, with the recent advances, the very low dose CT scan acquisitions can be perform with sufficient quality for the teeth analysis.
The goal of this study is to validate the use of dental CT for Demirjdian's staging method.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient aged between 0 and 25 years old
Key inclusion criteria (5 listed)
- Patient aged between 0 and 25 years old
- Complete dental panoramic
- CT scan including mandible and maxilla
- Maximum of 2 months between CT scan and dental panoramic
- Medical imaging available on the PACS
Key exclusion criteria (2 listed)
- Medical imaging missing on the PACS
- Patient refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
weighted Kappa test between CT scan
Time frame: day 1
weighted Kappa test between CT scan and dental panoramic assessment of Demirjian's staging of third mandibular molar
2 secondary outcomes
Mineralization difference
Time frame: day 1
Dental age estimation in a south french population
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Mandible Fracture
Active, not recruiting
Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation
Mandible Fracture, Force Measurement
Active, not recruiting
3D Printed Models for Mandibular Fracture Repair
Mandible Fracture, Maxillofacial Trauma
Not yet recruiting
Effect of Adipose Tissue Derived Autologous Mesenchymal Stem Cell Concentrate on Bone Quality in Mandibular Fracture Healing.
Mandible Fracture
RecruitingPhase 2
Comparison of Submucosal Dexamethasone and Methylprednisolone in Postoperative Sequelae of Parasymphsis Fractures
Mandible Fracture, Edema Face
RecruitingPhase 3
The MANTRA Trial (MANdibular TRauma and Antibiotic Use)
Mandible Fracture, Post-operative Antibiotics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine CYTEVAL, MD.PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mandible Fracture, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine CYTEVAL, MD.PhD (04 67 33 81 78 ext. 33, c-cyteval@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weighted Kappa test between CT scan (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021; AzTrials last refreshed its copy on 30 Oct 2026.